CClinicalTrials.gg
CompletedNCT00723905RemiTRACUpdated Jan 15, 2013

Remicade Infusion Management Program

An observational study in Crohn Disease and Arthritis, Rheumatoid, sponsored by Janssen Inc.. Completed at 2 sites in Canada. Per ClinicalTrials.gov, last updated 2013-01-15.

Sponsored by Janssen Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,630
Sex
All
01

Study summary

Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.

02

Conditions studied

  • Crohn Disease
  • Arthritis, Rheumatoid

Keywords

  • Crohn's Disease, Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 1,630 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Janssen Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn's Disease with infliximab.

Inclusion criteria

  • Subject is a good candidate to receive infliximab as per the Product Monograph
  • Subject is prescribed infliximab by an appropriate physician
  • Subject receives infusion in a community infusion centre.
  • Subject has signed the approved consent form.

Exclusion criteria

Exclusion Criteria:

  • Not specified in the protocol
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,630 participants (actual)
06

What researchers measure

Primary outcomes

  1. Type and frequency of infusion reactions

    Time frame: Up to 7 years

  2. Pre-infusion treatments and efficacy

    Time frame: Up to 7 years

  3. Infusion reaction management approaches

    Time frame: Up to 7 years

  4. The number of subjects with adverse events

    Time frame: Up to 7 years

07

Study locations

2 sites
  • Montreal, Quebec, Canada
  • Pointe-Claire, Canada
08

References and documents

Publications

  • Choquette D, Faraawi R, Chow A, Rodrigues J, Bensen WJ, Nantel F. Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry. J Rheumatol. 2015 Jul;42(7):1105-11. doi: 10.3899/jrheum.140538. Epub 2015 Jun 15. PubMed 26077415 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00723905
Lead sponsor
Janssen Inc.
Responsible party
Sponsor
First posted
Jul 29, 2008
Start date
Aug 2005
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Jan 15, 2013

Study contacts

Janssen Inc. Clinical Trial
study director · Janssen Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion